Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
telmisartan, Quantity: 80 mg
Alphapharm Pty Ltd
Telmisartan
Tablet
Excipient Ingredients: mannitol; meglumine; magnesium stearate; sodium hydroxide; sodium stearylfumarate; povidone
Oral
28
(S4) Prescription Only Medicine
MIZART is indicated for: - Treatment of hypertension - Prevention of cardiovascular morbidity and mortality in patients 55 years or older with coronary artery disease, peripheral artery disease, previous stroke, transient ischaemic attack or high risk diabetes with evidence of end organ damage (see CLINICAL TRIALS)
Visual Identification: White to off-white color, oval shape, biconvex, uncoated tablets debossed with L204 on one side and plain on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2015-08-13
MIZART ® _Telmisartan_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about MIZART. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking MIZART against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. This leaflet was last updated on the date at the end of this leaflet. More recent information may be available. The latest Consumer Medicine Information is available from your pharmacist, doctor, or from www.medicines.org.au and may contain important information about the medicine and its use of which you should be aware. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT MIZART IS USED FOR MIZART is used to: • treat high blood pressure (also called hypertension) • prevent cardiovascular complications, including death due to cardiovascular causes, in patients older than 55 years of age with coronary artery disease, peripheral vascular disease, previous stroke, previous transient ischaemic attack (TIA) or high risk diabetes with evidence of end organ damage. TREATMENT OF HYPERTENSION MIZART is used to lower high blood pressure (hypertension). Everyone has blood pressure. This pressure helps your blood move around your body. Your blood pressure may be different at different times of the day, depending on how busy or worried you are. You have hypertension (high blood pressure) when your blood pressure stays higher than normal, even when you are calm or relaxed. There are usually no signs of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated, it can lead to serious health problems, including stroke, heart disease and kidney failure. _HOW MIZART WORKS_ MIZART contains telmisartan. Telmisartan belongs to a Lue koko asiakirja
AUSTRALIAN PRODUCT INFORMATION MIZART ® _Telmisartan tablet_ _ _ 1 NAME OF THE MEDICINE Telmisartan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each MIZART tablet contains 40 mg or 80 mg of telmisartan as the active ingredient. Excipients with known effect: sulfites. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM 40 mg Tablet: MIZART tablets are white to off-white color, oval-shaped, biconvex uncoated tablets debossed with ‘L203’ on one side and plain on the other side. 80 mg Tablet: MIZART tablets are white to off-white color, oval-shaped, biconvex uncoated tablets debossed with ‘L204’ on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MIZART is indicated for: • Treatment of hypertension in adults • Prevention of cardiovascular morbidity and mortality in adult 55 years or older with coronary artery disease, peripheral artery disease, previous stroke, transient ischaemic attack or high risk diabetes with evidence of end organ damage (see Section 5.1 PHARMACODYNAMIC PROPERTIES, CLINICAL TRIALS) 4.2 DOSE AND METHOD OF ADMINISTRATION MIZART is available as tablets for oral administration. TREATMENT OF HYPERTENSION _Adults:_ The recommended dose is 40 mg once daily. In cases where the target blood pressure is not achieved, telmisartan dose can be increased to 80 mg once daily. When considering raising the dose, it must be borne in mind that, while reduction in blood pressure is achieved after the first dose, the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment. Telmisartan may be used in combination with thiazide-type diuretics such as hydrochlorothiazide or calcium-channel blockers such as amlodipine, which have been shown to have an additive blood pressure lowering effect with telmisartan. MIZART ® – PRODUCT INFORMATION 2 PREVENTION OF CARDIOVASCULAR MORBIDITY AND MORTALITY The recommended dose is 80 mg once daily. It is not known whether doses lower than 80 mg of Lue koko asiakirja